Upsilon Global

Global Regulatory Submissions Coordinator - Budapest

Location
Hungary
Salary
Competitive
Posted
11 Jun 2021
Closes
11 Jul 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Upsilon Global are working with an award winning mid-size global CRO that is present in over  35 locations globally and work in a number of therapeutic areas like oncology, CNS, cardiology, metabolic diseases and anti-infective in all phases.

They are seeking a Start-up Submissions Coordinator to join their team in Budapest in the Clinical Regulatory team.

The CRO offers great continuous career development and training and has been named one of the top work place by their employees globally. 

Responsibilties:

  • Prepare, review, and file clinical trial applications to country agencies;
  • Provide insightful input on regulatory submissions documents and timelines;
  • Ensure submissions comply with applicable regulations and guidance documents;
  • Advise on changing country regulations and compliance requirements; and
  • Track submissions and ensure timely filing of documents.

Qualifications:

  • A minimum of a Bachelor's degree is required (preferably in a Life Sciences field);
  • Some experience as a Regulatory Submissions Coordinator is preferred;
  • Excellent organization and communication skills;
  • Fluency in English;
  • Strong attention to detail;
  • Knowledge of Microsoft® Office; and
  • Hands-on experience preparing, reviewing, and submitting regulatory documentation is desirable.